NEW YORK – Medicare administrative contractors Novitas Solutions and First Coast Service Options on Thursday released final local coverage determinations that will rescind coverage for nine genetic tests for cancer.
The affected tests are Castle Biosciences' DecisionDx-SCC test; Pacific Edge Diagnostics' Cxbladder Detect, Enhanced Cxbladder Detect, Cxbladder Monitor, and Cxbladder Triage assays; Interpace Biosciences' PancraGen; Clinical Genomics' Colvera; and the University of Pittsburgh Medical Center's ThyroSeq Cancer Risk Classifier and PancreaSeq Genomic Classifier.
In June 2022, the two MACs issued draft LCDs for cancer genetic tests and allowed the public to comment on them. However, in June 2023, Novitas and FCSO released two final — and much longer — LCDs limiting coverage for the above tests as well as Castle Biosciences' DecisionDx-Melanoma assay, Abbott's UroVysion fluorescence in situ hybridization test, and Pacific Edge Diagnostics' Enhanced Cxbladder Triage and Cxbladder Resolve assays. The final LCDs included coverage terms that were not covered in the draft decisions, sparking outcry from industry stakeholders who said that the public hadn't had the chance to provide feedback on the changes.
One month later, both MACs rescinded their original decisions and re-released them as draft LCDs, allowing public comments until September 2023. A group of 44 organizations, including the American Clinical Laboratory Association, the Association for Molecular Pathology, and the American College of Medical Genetics and Genomics, submitted a letter to the MACs raising concerns that the coverage criteria would harm Medicare beneficiaries by limiting access to necessary genetic tests.
The new finalized LCDs released on Thursday have granted UroVysion limited coverage, but removed DecisionDx-Melanoma coverage because claims for the test are not processed within Novitas' or FCSO's jurisdictions, and removed Enhanced Cxbladder Triage and Cxbladder Resolve coverage because the tests are not yet commercially available.
In addition, the draft LCDs only allowed for coverage of molecular testing that was endorsed by the National Comprehensive Cancer Network's compendium or guidelines, the Clinical Genome Resource, or the Memorial Sloan Kettering Cancer Center-sponsored Oncology Knowledge Base. The final LCDs have removed that requirement.
Under the new LCDs, UroVysion is covered when it is used to clarify indeterminate or nondiagnostic cytology results in patients with persistent gross or microscopic hematuria who are suspected of having urothelial cancer after undergoing a complete history and physical, cystoscopy, and imaging of the urinary tract, or when the test is used for surveillance in patients already diagnosed with non-muscle invasive bladder cancer who are under evaluation for the response to intravesical Bacillus Calmette-Guerin.
In addition to the specific genetic tests listed, the new LCDs also generally do not allow genetic testing in patients who don't have either an established diagnosis of cancer or substantiated suspicion of cancer as determined by a clinical evaluation and abnormal results from histologic, cytologic, and/or flow cytometric examination.
Not covered is genetic testing of asymptomatic patients to screen the patients or their relatives, as well as repetitions of the same genetic test on the same genetic material, such as revalidations, quality control, or failure of a first test attempt.
For genetic testing to be covered, the ordering provider must be the treating clinician who is responsible for the management of the patient's cancer, understand how the test result will impact the patient's condition, and have presented the information to the patient and elicited patient understanding. Genetic testing must also directly impact the management of the patient's specific condition.
Following the LCD, Interpace Biosciences said it would stop offering the PancraGen test effective Feb. 7 as a result of Novitas' and FCSO's decisions. Interpace President and CEO Tom Burnell said that the decision "is inconsistent with advancing medicine and goals to improve the quality of patient care." He added that Interpace will "consider any and all remedies or actions against Novitas/CMS [but] the impending loss of Medicare reimbursement will necessitate the restructuring of Interpace."
The firm has developed a plan and is ready to implement it. Even without PancraGen, Interpace can sustain its operations, "and we expect that our testing franchise for indeterminant thyroid nodules, ThyGenext and ThyraMir v2, will allow us to remain profitable in 2025 and beyond," Burnell said.
BTIG analyst Mark Massaro wrote in a note to investors that in his view, Novitas did not cite more recent evidence supporting the clinical validity and utility of Castle Bio's DecisionDx-SCC assay. If Novitas did not review that evidence, Massaro said the MAC could possibly update its LCD again through an appeal or reconsideration request.
The final LCDs will go into effect on Feb. 23.